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LeadingEdge Personnel

Quality Assurance Lead

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Job Description

Location:
77386
Salary:
30-36 but negotiable
Schedule:
Monday-Friday, 7:00 AM-5:00
PM Type:
Full-Time Industry:
Manufacturing QA/QC Lead Growing dietary supplement contract manufacturer specializing in powder and capsule products is seeking an experienced, hands-on QA/QC Lead to oversee daily quality activities and strengthen quality systems. Key Responsibilities Lead daily QA/QC activities, including raw material review, in-process checks, batch record review, and finished-product release. Ensure compliance with
FDA 21 CFR
Part 111, cGMP , and company quality procedures. Support
NSF/ANSI 455-2
certification requirements. Review/approve batch records, specifications, COAs, SOPs, and controlled quality documents. Manage deviations, nonconformances, investigations, RCA and CAPAs , including effectiveness checks. Review laboratory results and coordinate OOS investigations and third-party testing. Perform line-clearance verification, production-area audits, and in-process quality checks. Maintain material/product hold, quarantine, release, and disposition controls. Support FDA, NSF, customer, and third-party audits and maintain audit readiness. Maintain and improve SOPs, specifications, change controls, quality records, and document control. Support supplier qualification, customer complaints, sanitation verification, environmental/allergen/microbiological monitoring, calibration, and training programs. Train production personnel on cGMP, SOPs, quality procedures, and documentation practices. Work closely with Production, Warehouse, Purchasing, Sales, and leadership to resolve quality issues. Identify and implement improvements to quality systems and processes. Required Qualifications 2+ years of hands-on QA/QC experience in dietary supplements, nutraceuticals, pharmaceuticals, food manufacturing, or another FDA-regulated manufacturing environment. Working knowledge of cGMP quality systems . Experience with SOPs, investigations, deviations, CAPAs, RCA, and quality documentation. Experience reviewing manufacturing/batch records and supporting product disposition. Strong organizational, communication, and problem-solving skills. Ability to work independently and take ownership in a fast-paced manufacturing environment. Preferred Dietary supplement/nutraceutical manufacturing experience. Knowledge of
FDA 21 CFR
Part 111 and/or
NSF/ANSI 455-2
. FDA, NSF, customer, or third-party audit experience. Supplier quality management and third-party laboratory experience. Familiarity with HPLC, ICP-MS, FTIR, or similar analytical testing. Bachelor's degree in Quality, Food Science, Chemistry, Biology, Pharmaceutical Sciences, or related field.
Ideal candidate:
A hands-on quality professional who can own day-to-day QA/QC, make sound quality decisions, investigate problems, implement corrective actions, and continuously improve the qualit
Pay:
$30.00 - $36.00 per hour Expected hours: 40.0 per week Application Question(s):
NSF/ANSI 455-2
Required Work Location:
In person